NCT02384629撤回4 期
PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Late loss of side branch(SB)
研究概览
简要总结
- To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
- To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures,
- •Patients ≥ 19 years old,
- •Patients who are expected to undergo PCI for bifurcation lesions.
排除标准
- •Age> 85 years,
- •Cardiogenic shock or unstable patients,
- •Increased risk of bleeding, anemia, thrombocytopenia,
- •A need for oral anticoagulation therapy,
- •Pregnant women or women with potential childbearing,
- •Life expectancy < 1 year.
研究组 & 干预措施
AXXESS stent1
Experimental
AXXESS stent (OCT-guided)
干预措施: OCT-guided PCI with AXXESS stent (Device)
Conventional DES1
Experimental
Conventional DES (Biomatrix flex stent, OCT-guided)
干预措施: OCT-guided PCI with conventional DES (Biomatrix flex stent) (Device)
AXXESS stent2
Active Comparator
AXXESS stent (Angio-guided)
干预措施: Angio-guided PCI with AXXESS stent (Device)
Conventional DES2
Active Comparator
Conventional DES (Biomatrix flex stent, Angio-guided)
干预措施: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent) (Device)
结局指标
主要结局
Late loss of side branch(SB)
时间窗: 9 months after procedure
Late loss was defined as the difference between the minimal luminal diameter (MLD) immediately after the procedure and the MLD at 9-month follow-up, Measured the change in MLD by Quantitative coronary angiography (QCA)
次要结局
- Cardiovascular (CV) death(9 months after procedure)
- Myocardial infarction (MI)(9 months after procedure)
- stent thrombosis (ST)(9 months after procedure)
- SB closure(9 months after procedure)
研究者
相似试验
已完成
不适用
Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent ImplantationCoronary Artery DiseaseNCT02486315Clinica Mediterranea326
已完成
4 期
POLish Bifurcation Optimal Stenting StudyCoronary Artery DiseaseNCT02192840Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland243
已完成
不适用
XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in DeliveryCoronary Artery DiseaseAtherosclerosisNCT00731237Abbott Medical Devices2,517
已完成
不适用
AXIOS Stent With Electrocautery Enhanced Delivery SystemPancreatic Pseudocyst(s)NCT02146352Xlumena, Inc.30
已完成
不适用
AXIOS CHINA (E7148)Pancreatic Pseudocyst and Walled-off NecrosisNCT03808272Boston Scientific Corporation31